Subcoated simulated capsule-like medicament

ABSTRACT

A simulated capsule-like medicament comprising a subcoating of a mixture of a water-soluble, film-forming polymer, e.g. hydroxypropylmethyl cellulose and a hydrophobic plasticizer, e.g. castor oil, which promotes a smooth uniform and substantially bubble free outer coating, e.g. gelatin, for the capsule-like medicament; capsule-like medicaments which are slightly bowed in shape; and a process of making such medicaments.

[0001] This invention is a continuation-in-part of Ser. No. 07/345,599filed on Apr. 28, 1989 entitled “Subcoated Simulated Capsule-LikeMedicament” the text of which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] This invention relates to subcoated simulated capsule-likemedicaments. More particularly this invention relates to a solidmedicament caplet core which has been subcoated with a mixture of awater-soluble, film-forming polymer and a hydrophobic plasticizer andcoated with a smooth outer coating to provide the appearance of acapsule-like medicament and a process of making such coated medicaments.

BACKGROUND OF THE INVENTION

[0003] Filled two-piece gelatin capsules for the encapsulation ofvarious medicinal agents have been used for administering drugs sincethe mid-19th century. This capsule form of medicament proved to be verypopular because hard gelatin capsules are tasteless, easily administeredand easily filled either at a pharmacy or pre-filled in large quantitiesat commercial plants. While hard shell gelatin capsules are stillpopular dosage forms for pharmacist dispensed medicaments they havegenerally been discontinued in many over-the-counter products because ofthe risk of tampering with their contents.

[0004] Absent the susceptibility of capsule form medicaments totamperings the capsule form was extremely popular with consumers becauseof a number of advantages. Many consumers prefer the gelatin form ofcapsule because of the perceived efficacy, taste, feel andswallowability of the gelatin capsule form of medicament.

[0005] This consumer preference for gelatin capsule-like medicamentsprovided a challenge to the industry to produce capsule-like medicamentswhich are tamper-proof yet provide the consumer with the advantages of ahard shell gelatin capsule-like dosage form. Norbert I. Berta developedsimulated capsule-like medicaments and a process for making suchcapsule-like medicaments as disclosed in his U.S. Pat. No. 4,820,524.The entire disclosure of this issued U.S. patent is hereby incorporatedherein by reference. Norbert I. Berta has also developed variations ofthe processes for making simulated capsule-like medicaments andapparatus for producing such medicaments as disclosed in co-pending U.S.patent application Ser. Nos. 129,108 filed Dec. 4, 1987; 129,109 filedDec. 4, 1987; 190,551 filed May 5, 1988; and 190,616 filed May 5, 1988.The simulated capsule-like medicaments developed by Berta wereresponsive to a long felt need in the industry to provide a simulatedsubstitute for the popular dosage form of gelatin capsules. Whilegelatin coating of uncoated compressed medicaments such as acetaminophenis possible in accordance with the invention of Berta, it is difficultto control the quality of the surface appearance of such gelatin-coatedcaplets.

[0006] Beyond the development of a simulated capsule-like medicamentseveral factors and considerations must be met to commercially produce acapsule which has a smooth, uniform and substantially bubble free outercoating appearance. A preferred gelatin-coated caplet is one in whichtwo distinctly colored gelatin coating solutions are utilized to producea bi-colored gelatin-coated caplet. The two overlapping distinctlycolored gelatin coatings form a seam about the transverse axis of themedicament. The presence of this seam and the distinct bi-coloringcontributes to the consumer's perception of these simulated capsule-likemedicaments as equivalents to gelatin capsule dosage forms.

[0007] The gelatin coated caplet product must adequately simulate acapsule-like medicament from a consumer's sight and touch perspectiveand must therefore be absent of discoloration, pits and gouges. Thepresence of such physical imperfections may erode the consumer'sperception as to the gelatin coated caplet's capsule-like nature and thetamper-free nature of this dosage form. Strong consumer confidence inthe gelatin capsule-like nature and tamper-resistance of the simulatedcapsule medicament of the invention is of the utmost importance in themarketing of this dosage form and forms an object of the presentinvention. It is therefore an object of the present invention to providea subcoating for a solid caplet medicament core which minimizes bubbleformation, discoloration and other aesthetic imperfections to providefor a smooth, uniform and substantially bubble free outer coatingappearance to simulated capsule-like medicaments.

SUMMARY OF THE INVENTION

[0008] The foregoing object of providing a simulated capsule-likemedicament which has a smooth, uniform and substantially bubble freeouter coating appearance has now been accomplished in accordance withthe compositions and processes of the present invention.

[0009] In accordance with the purposes of the invention, as embodied andfully described herein, the invention comprises a simulated capsule-likemedicament comprising: a solid caplet core comprising a medicament; asubcoating composition on the caplet core comprising a mixture of awater-soluble, film-forming polymer and a hydrophobic plasticizer; and asmooth outer coating whereby the subcoating composition promotes asmooth, uniform and substantially bubble free outer coating appearanceto the capsule-like medicament.

[0010] In another embodiment of the present invention, there is provideda swallowable solid core having a smooth, uniform and substantiallybubble free outer coating comprising a solid core containing amedicament which has an exterior surface that is coated with asubcoating composed of a mixture of a water-soluble, film-formingpolymer selected from the group consisting of hydroxypropyl cellulose,hydroxypropylmethyl cellulose, mixtures of hydroxypropyl cellulose andhydroxypropylmethyl cellulose, mixtures of hydroxypropyl cellulose andmethyl cellulose wherein the hydroxypropyl cellulose constitutes greaterthan 50 weight percent but less than 100 weight percent of the mixtureof hydroxypropyl cellulose and methyl cellulose, mixtures ofhydroxypropyl cellulose and hydroxyethyl cellulose wherein thehydroxypropyl cellulose constitutes greater than 80 weight percent butless than 100 weight percent of the mixture of hydroxypropyl celluloseand hydroxyethyl cellulose, mixtures of hydroxypropylmethyl celluloseand methyl cellulose wherein the hydroxypropylmethyl celluloseconstitutes greater than 50 weight percent but less than 100 weightpercent of the mixture of hydroxypropylmethyl cellulose and methylcellulose, mixtures of hydroxypropylnethyl cellulose and hydroxyethylcellulose wherein the hydroxypropylmethyl cellulose constitutes morethan 80 weight percent but less than 100 weight percent of the mixtureof hydroxypropylmethyl cellulose and hydroxyethyl cellulose andcombinations of two or more thereof; and castor oil, wherein thesubcoating provides an outer subsurface which is coated with agelatinous coating, wherein the subcoating is provided in an amountwhich is effective to promote a smooth, uniform and substantiallybubble-free outer coating appearance to capsule-like medicaments.

[0011] In preferred embodiments of the invention the water-soluble,film-forming polymer is hydroxypropyl-methylcellulose, the hydrophobicplasticizer comprises castor oil and the smooth outer coatingcomposition is gelatin. In more preferred embodiments, thehydroxypropyl-methylcellulose and castor oil comprise from about 2 toabout 8%, more preferably about 4 to about 6%, and most preferably about4% by weight of the total weight of the subcoated caplet core.

[0012] In further preferred embodiments of the invention the medicamentcomprises a composition selected from the group consisting ofacetaminophen, ibuprofen, loperamide, naproxen, pseudoephedrine,dextromethorphan, chlorphenarimine, and mixtures thereof.

[0013] In further preferred embodiments a solid caplet core of thecapsule-like medicament has a slight convex bowed shape. Preferably, thebow represents an arcuate variance of about 1 to 5 degrees about alongitudinal axis of the caplet core.

[0014] As embodied and broadly described herein the invention furthercomprises a process for preparing a simulated capsule-like medicamentcomprising the steps of: compressing a mixture of a medicament andpharmaceutically acceptable excipients to form a solid caplet core;applying a subcoating composition comprising a mixture of awater-soluble, film-forming polymer and a hydrophobic plasticizer to thesolid caplet core; and applying a smooth outer coating to the subcoatedcaplet core to provide a smooth, uniform and substantially bubble freeouter coating appearance to the capsule-like medicament. The preferredcomponents for the caplet core and the subcoating mixture are asdescribed above. In preferred embodiments of the process of theinvention the outer coating is gelatin and is applied at a temperatureof from about 35 to 55° C., preferably at about 40 to 50° C.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015]FIG. 1 is a front-top perspective view of a caplet core of theinvention;

[0016]FIG. 2 is a top plan view of the caplet core;

[0017]FIG. 3 is a side elevational view of the caplet core;

[0018]FIG. 4 is a front elevational view of the caplet core; and,

[0019]FIG. 5 is a top plan view of a caplet of the prior art.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

[0020] Reference will now be made in detail to preferred embodiments ofthe invention, examples of which are illustrated in the followingexamples section.

[0021] The present invention provides a subcoating which is suitable forcoating any swallowable solid core which will be subsequently coatedwith a gelatinous outer layer. The solid core may be of any shape whichis suitable for the oral administration of drug substances including butnot limited to tablet or capsule shapes. Suitable method ofmanufacturing solid cores are well known in the art such as thetechniques on pages 1576-1607 of Remington's Pharmaceutical Sciences,Mack Publishing Company (Fifteenth edition), 1975 the text of which ishereby incorporated by reference. Currently the preferred solid coreshapes for subcoating are solid core capsule-like shapes hereinafterreferred to as caplets.

[0022] To achieve one of the object of the invention which is to providea simulated capsule-like medicament which has a smooth, uniform andsubstantially bubble-free outer coating appearance, a subcoating isapplied to the solid caplet medicament core to provide a compatiblecoating surface for the gelatinous coating. The subcoating compositionin accordance with the invention provides a surface for gelatinouscoating that minimizes bubble formation, discoloration and otheraesthetic imperfections.

[0023] The capsule-like medicament of the invention comprises a solidcaplet core of a medicament which can be compressed into a caplet coreutilizing conventional excipients and tableting aids. Any pharmaceuticalactive or medicament that is capable of being formed into a caplet core,may be used in accordance with the invention. Examples of suitablemedicaments which may be utilized in accordance with the inventioninclude, but are not limited to, acetaminophen, ibuprofen, loperamide,naproxen, pseudoephedrine, dextromethorphan, chlorphenarimine, andmixtures thereof. These medicaments may be used alone or in combinationsuch as a sinus headache combination comprising for example,acetaminophen and pseudoephedrine.

[0024] The subcoating composition of the present invention was developedto provide multiple functions required for a suitable subcoat. Thesefunctions and characteristics of the subcoat or pre-coat include thefollowing: adequate film strength of the subcoating to allow thesubcoated tablet to withstand mechanical transfer and maintain theintegrity of the subcoat; compatibility of the subcoat material with themedicament to be coated; compatibility of the subcoat material with thesmooth outer coating such that adequate pick-up of the smooth outercoating is achieved with a minimum of bubble formation on the finalproduct; and compatibility of the subcoat material with the outercoating such that the subcoat does not adversely affect the color of theouter coating composition particularly where two distinct colors areutilized.

[0025] The subcoating composition of the invention also providesadvantageous processing functions. The subcoating helps eliminate dustand other degradation of the medicament caplet core. The subcoating alsoprevents contamination of the gelatin coating solution by the medicamentpresent by providing a full separation barrier between the gelatincoating solution and the medicament in the subcoated solid caplet core.

[0026] In accordance with the present invention, it was found that asubcoating composition which accomplishes the required functionscomprises a mixture of a water-soluble, film-forming polymer and ahydrophobic plasticizer.

[0027] One suitable group of water-soluble film-forming polymers arecellulose derivatives selected from the group consisting ofhydroxypropylmethyl cellulose ( hereinafter also referred to as HPMC)and hydroxypropyl cellulose (hereinafter also referred to as HPC) whichmay be used individually or combined in mixtures. Hydroxypropylmethylcellulose and hdyroxypropyl cellulose may also be combined with othercellulose derivatives such as methyl cellulose and hydroxyethylcellulose. The amount of HPMC and/or HPC present in mixtures with methylcellulose should be in the range of from about 50 weight percent to lessthan 100 weight percent of HPMC and/or HPC based on the dry weight ofthe components equalling 100 weight percent. The amount of HPMC and/orHPC present in mixtures with hydroxyethyl cellulose should be in therange of from about 80 mole percent to less than 100 weight percent ofHPMC and/or HPC present in the mixture based on the dry weight of thecomponents of the mixture equalling 100 weight percent. The molecularweight of the water-soluble film-forming polymers utilized in thepresent invention is not believed to be critical to the practice of thepresent invention. It is however recommended that the average molecularweight of the water-soluble film-forming polymer be in the range of fromabout 50,000 to 150,000. Suitable grades of hydroxypropylmethylcellulose polymers within these weight ranges may be obtained from DowChemical Company designated as E50 and E150. Currently preferredwater-soluble film forming polymers are hydroxypropylmethyl cellulosepolymers having a molecular weight of about 50,000. The degree ofsubstitution of the cellulose derivative utilized in the subcoatingshould conform to the degree of substitution approved for this use bythe FDA. For example the degree of substitution of HPMC should be in therange of from 19-30 percent methoxyl substitution and from 4-12 percentpropyl substitution and preferably in the range of from 28-30 methoxylpercent and 7-12 percent propyl. Methyl cellulose should be substitutedin the range of from 27.5-31.5 percent methoxy groups. The currentlypreferred hydrophobic plasticizer is castor oil. The amount ofsubcoating composition utilized should be an amount effective to providethe above-mentioned desirable functions and characteristics of thesubcoated caplet core.

[0028] Optimization of the coating amount will vary in accordance withthe size of the caplet core and particular medicaments utilized.Preferably, a mixture of the water-soluble film forming polymer (forexample the preferred hydroxypropylmethyl cellulose) and castor oilcomprises from about 2 to about 8%, more preferably about 4 to about 6%and most preferably about 4% by weight of the total weight of thesubcoated caplet core. The amount of castor oil present as a hydrophobicplasticizer comprises from about 0.1 to about 1% by weight of the totalweight of the subcoated caplet core. Preferably the amount ofwater-soluble film-forming polymer e.g. hydroxypropylmethyl cellulose,to the hydrophobic plasticizer e.g. castor oil, is on the order of about20:1.

[0029] It is important that the outer coating of the simulatedcapsule-like medicament be smooth, uniform and substantially bubble freeto provide the perception of a capsule-like medicament. To achievesuperior simulation of gelatin capsule dosage forms it is preferred touse a dual color outer coating which meets at a distinct seam at aboutthe middle of the coated medicament caplet. The preferred outer coatingcomposition is gelatin whereby the subcoated caplet core is dipped intoa gelatinous solution. More preferably opposite ends of a subcoatedmedicament caplet core are dipped into two gelatinous solutions ofdistinct color to produce a dual colored capsule-like medicament. Theamount of gelatinous coating added to the product is dependent upon theouter appearance desired for the product. Generally, enough gelatinouscoating must be added on to the caplet to provide a smooth uniform andbubble free outer coating appearance and provide a gelatinous feel tothe touch and in the mouth of consumers swallowing the simulatedcapsule-like medicament. A preferred gelatinous coating add-on is about6.0 to about 8.3% by weight of the total weight of the simulatedcapsule-like medicament.

[0030] It is also recommended that the gelatin coating utilized in thepresent invention for coating the caplet surface be provided in anaqueous solution having a gelatin concentration of from in the range ofabout 20 weight percent to about 40 weight percent gelatin. The apparentviscosity of this gelatin solution is recommended to be in the range offrom about 800 to about 1000 cps as measured at about 40° C.-50° C.temperature on a Brookfield viscometer. The preferred gelatin for thepractice of the present invention is a mixture of in the range of fromabout 60 weight percent to about 80 weight percent of bone gelatin andin the range of about 40 weight percent to about 20 weight percent ofpork gelatin on a dry weight basis with the total weight percent of thedry components totalling 100 weight percent. The currently preferredgelatin mixture is 70 weight percent bone gelatin and 30 weight percentpork gelatin.

[0031] In preferred embodiments the capsule-like medicament of theinvention has a caplet core which has a slight convex bowed shape. Thisshape is illustrated in FIGS. 1-4 herein which are described in moredetail below. This bowed shape serves two important functions. It wasfound that caplets of the prior art that were unbowed or had straightedges were more prone to stick to each other and form “twins.” Formationof twins or twinning is the joining of one or more caplets togetherduring processing along edges in contact with each other. Further,caplets with straight edges also tend to stick or twin togethertemporarily and cause surface imperfections, e.g. pitting and/orgouging. Twinning of straight edged prior art caplets is illustrated inFIG. 5 herein, which is described in more detail below.

[0032] Twinning of caplets can apply to any situation where the capletcores have a tacky or sticky outer coating due to the nature of theingredients comprising the medicament or those comprising the subcoatingor gelatinous outer coating of the caplets. For example, coatings suchas shellac, seal coatings, or sugar coatings also provide tacky capletswhich are prone to form twins. It is therefore advantageous in preparingsimulated capsule-like medicaments in accordance with the presentinvention, as well as, the handling of all tacky caplet cores to utilizecaplets which have a slight bowed shape which reduces twinning ofcaplets due to contact during processing. The bowed shape minimizes thepoint of contact between caplets and thus reduces sticking or twinningof caplets to each other.

[0033] In preferred embodiments of the present invention, the bowing isa convex bow that stems from the middle of a longitudinal axis of thecaplet core outwards toward the two ends. The bowed variance along thelongitudinal axis of the caplet core is on the order of about 1 to 5degrees. This arcuate variance is great enough to reduce the twinning ofthe caplets during processing without detracting from the capsule-likeshape and appearance of the final medicament product which is importantto its simulation of a gelatin capsule.

[0034] Another surprising advantage of providing caplets with a slightlyconvex bowed shape is that the shape provides an increase in tablethardness of up to about 10% as compared with regular unbowed capletshaped cores. The increase in hardness may be due to some degree to theincreased thickness of the caplet about the center area but themagnitude of increase achieved could not be anticipated by this slightchange in thickness at this area. It has also been found advantageous toprovide a convex bow shaped caplet since the increased hardnesscontributes to preventing surface pitting and breaking of the coresduring the coating process.

[0035] The bow shaped caplet core of the invention will now be describedwith reference to the Figures herein. FIG. 1 is a perspective view of acaplet core (1) from the top (3), front (5) and right (7) sides. Aperipheral edge surface or “belly band” (9) extends longitudinallyaround the side of the caplet core (1). FIG. 2 shows a top plan view ofthe caplet core (1) with adjacent caplet cores (11) shown in brokenlines on either side of the caplet core (1) at their belly bands (9) and(13). In accordance with the slight bowed shape of the belly bands (9)and (13) the adjacent caplet cores have only a single point of contact(15) with each other along the arcuate edge surface of the belly band.The amount of bowing need only be slight, on the order of 1 to 5 degreesas is illustrated by angle V in the drawing. FIG. 3 is a sideelevational view of the caplet core (1) and belly band (9). FIG. 4 is afront elevational view of the caplet core (1) and belly band (9).

[0036]FIG. 5 is a view similar to FIG. 2 showing a straight edged orunbowed caplet core (50) of the prior art with adjacent or twinnedcaplet cores (52) in contact therewith along straight edged belly bands(54) with a point of contact along the entire straight edge of thecaplet core as illustrated by the dimension (56) marked out by lengthindicators (58) and (60). This large potential area of contact along theentire straight edge (56) of caplet cores of the prior art encouragessticking or twinning of caplets to each other and production of surfaceimperfect or twinned caplets which are not suitable for furthercommercial use as simulated capsule-like medicaments.

[0037] In accordance with the present invention, a process is alsoprovided for preparing simulated capsule-like medicaments. The processcomprises the steps of compressing a mixture of medicament andcompatible excipients to form a solid caplet core. The excipients chosenand the compression applied should be adequate to provide a caplet withsufficient hardness for prevention of surface pitting and capletbreakage during coating of the caplet core. For capsule-likeacetaminophen medicaments the preferred hardness is about 10-14 Kp andmore preferably about 10-11 Kp.

[0038] To provide a capsule shape appearance the width to thicknessratio about the simulated capsule-like medicament should be as close aspossible to one. Gelatin capsule dosage forms are generally round inshape and therefore have a width to thickness ratio by definition ofone. A preferred tooling dimension which gives this appearance is 0.750inches by 0.250 inches by 0.075 inches. The thickness resulting fromthis tooling is 0.244 inches. These dimensions may vary as the size ofthe caplet varies but efforts should be made to keep the width tothickness ratios as close as possible to one to provide adequatesimulation of a gelatin capsule dosage form.

[0039] The subcoating composition, preferably a mixture ofhydroxypropylmethyl cellulose and castor oil, is applied from an 8%weight by weight aqueous solution. Acceptable subcoatings can be appliedwith subcoating solutions of from 6 to 8% concentration but 8% ispreferred since a shorter amount of spraying time is required to providethe desired amount of subcoating on the caplet core. Coating levelsabove 8% were found to provide less desirable subcoatings because ofunevenness of application of the subcoating composition. Theconcentration of the subcoating solution is not considered critical tothe coating process. The caplet cores are subcoated to preferablyprovide about 2 to 8%, more preferably about 4 to 6 and most preferablyabout 4% subcoating by weight of the total weight of the subcoatedcaplet core.

[0040] A smooth outer coating is applied to the subcoated caplet core toprovide a smooth, uniform and substantially bubble free outer coatingappearance to the capsule-like medicament. The preferred outer coatingis a gelatin outer coating and more preferably a bicolor gelatincoating. Application of the gelatinous coating is by dipping of thesubcoated caplet core into a gelatin solution which has a temperature inthe range of about 35-55° C., preferably about 40 to 50° C. Highergelatin solution temperatures generally result in a lower viscosity ofthe gelatin solution. The gelatin solution temperature is varied toadjust the viscosity and gelatin pick-up on the subcoated caplet.

[0041] Gelatin dipping may be performed by any adequate means includinghand dipping of the caplets into a gelatin solution. A particularlypreferred method is performed in accordance with the teachings of Bertain the aforementioned U.S. Pat. Nos. 4,820,524 which has beenincorporated herein by reference. This patent provides a useful processfor providing bi-color gelatin coated capsule-like medicaments whichhave a slightly raised seam about the color overlapping portion of thecaplet which contributes to its simulated capsule-like feel andappearance. Any color gelatin solutions may be utilized, but it ispreferred that the colors be distinct.

EXAMPLE

[0042] The invention will now be illustrated by example. The example isnot intended to be limiting of the scope of the present invention butread in conjunction with the detailed and general description aboveprovide further understanding of the present invention and an outline ofa process for preparing the compositions of the invention.

Example 1 Simulated Capsule-Like Acetaminophen Dosage Form

[0043] An acetaminophen caplet core was prepared from the followingcomponents: I. - Active and Excipients Mg/Caplet acetaminophen, USP500.0 mg powdered cellulose, NF 40.0 mg pregelatinized starch, NF 10.0mg sodium starch glycolate, NF 10.0 mg II. - Granulating Agent starch,NF 40.0 mg purified water, USP q.s. III - Dry Adds magnesium stearate,NF 3.20 mg Total 603.2 mg

Working Directions

[0044] A. Weigh the desired components of Part I in the proportionsprovided and add them to a bowl of a fluid bed granulator such as anAEROMATIC brand granulator.

[0045] B. Prepare the granulating agent (Part II) by adding the purifiedwater to a processing tank with approximately 15 grams of water for eachgram of starch NF. Slowly mix in the starch and heat the mixture untilthe temperature reaches about 82-84° C.

[0046] C. With the components of Part I in a heated fluidized state andan inlet air temperature of 75-85° C., spray the granulating agent ontothe powders.

[0047] D. After all the granulating agent has been sprayed, dry thegranulated powders to a moisture content of about 1.4 to 1.9% asdetermined by loss on drying using for example a COMPUTRAC brandanalyzer.

[0048] E. Sieve the dried granulation, for example, using a GLATT QUICKbrand sieve stator No. 3, screen No. 1.5 mm, 1,000 RPM.

[0049] F. Blend the sieved and dried granulation with the powders ofPart III using a suitable mixer such as a twin shell, ribbon orplanetary mixer.

[0050] G. Load the granulation into a tableting machine and compress thecaplets using a capsule-shaped tooling device of the dimensions0.750″×0.250″×0.075″×. The thickness resulting from this tooling is0.244″. Ideal caplet hardness is about 10 Kp.

[0051] H. Coat the compressed solid caplet cores of step G by sprayingwith an 8% aqueous solution which comprises a mixture ofhydroxypropylmethyl cellulose and castor oil in a ratio of about 20:1(this mixture is commercially available from Colorcon as OpadryYS-5-7042). The subcoating solution is applied utilizing a Accla-Cotaperforated pan coating unit manufactured by Thomas Engineering (HoffmanEstates, Ill.) to achieve a 4% subcoating by weight of the total weightof the subcoated caplet core.

Gelatin Dipping

[0052] The subcoated caplet core is then subjected to gelatin dipping.The gelatin used is preferred to be a mixture of 70 weight percent boneand 30 weight percent pork gelatin which may be obtained separately fromKind and Knox. The gelatin solution for dipping was a 30 weight percentaqueous solution with an apparent viscosity of about 800-1,000 cps asmeasured at 40° C. by a Brookfield viscometer. The gelatin dipping maybe accomplished by hand e.g. by dipping half of the subcoated capletcore into a yellow gelatin solution at about 40° C. for about 6 secondsand withdrawing the half coated caplet and allowing it to dry beforedipping the as yet non-gelatin coated half of the caplet into a redgelatin solution at a temperature of 40° C. for about 6 seconds. Wherebya slight overlapping of the two distinctly colored gelatinous cores isachieved about the midway portion of the caplet.

[0053] The caplet may also be gel dipped in accordance with the processand apparatus as described in U.S. Pat. No. 4,820,524 of Berta which hasbeen incorporated herein by reference.

[0054] The scope of the present invention is not limited by thedescription, examples and suggested uses herein and modifications can bemade without departing from the spirit of the invention. For example,other components may be added to the caplet core including variousflavorings, preservatives and other pharmaceutical excipients. Thepresent invention may also be provided in a sustained releaseformulation wherein the caplet core comprises a medicament and sustainedrelease promoting excipients. The simulated capsule-like compositionsand slightly bowed caplets may also be applicable to non-medicinalapplications such as oral dosage forms of vitamins and/or othernutrients.

[0055] Application of the compositions and processes of the presentinvention for medical and pharmaceutical uses can be accomplished byclinical, medical and pharmaceutical methods and techniques as arepresently or prospectively known to those skilled in the art.

[0056] Thus it is intended that the present invention cover themodifications and variations of this invention provided that they comewithin the scope of the appended claims and their equivalents.

What is claimed is:
 1. An oral medicament having a smooth, uniform andsubstantially bubble-free gelatinous outer coating comprising aswallowable solid core containing a pharmaceutical active which has anexterior surface that is coated with a subcoating composed of a mixtureof a water-soluble film-forming polymer selected from the groupconsisting of hydroxypropyl cellulose, hydroxypropylmethyl cellulose,mixtures of hydroxypropyl cellulose and hydroxypropylmethyl cellulose,mixtures of hydroxypropyl cellulose and methyl cellulose wherein thehydroxypropyl cellulose constitutes greater than 50 weight percent butless than 100 weight percent of the mixture of hydroxypropyl celluloseand methyl cellulose, mixtures of hydroxypropyl cellulose andhydroxyethyl cellulose wherein the hydroxypropyl cellulose constitutesgreater than 80 weight percent but less than 100 weight percent of themixture of hydroxypropyl cellulose and hydroxyethyl cellulose, mixturesof hydroxypropylmethyl cellulose and methyl cellulose wherein thehydroxypropylmethyl cellulose constitutes greater than 50 weight percentbut less than 100 weight percent of the mixture of hydroxypropylmethylcellulose and methyl cellulose, mixtures of hydroxypropylmethylcellulose and hydroxyethyl cellulose wherein the hydroxypropylmethylcellulose constitutes more than 80 weight percent but less than 100weight percent of the mixture of hydroxypropylmethyl cellulose andhydroxyethyl cellulose and combinations of two or more thereof; andcastor oil, wherein the subcoating provides an outer subsurface which iscoated with a gelatinous coating, wherein the subcoating is provided inan amount which is effective to promote a smooth, uniform andsubstantially bubble-free outer coating appearance to the oralmedicament.
 2. The oral medicament of claim 1 wherein the solid core hasa capsule-like shape which is slight bowed in shape.
 3. The capsule-likemedicament of claim 2 wherein the bowed shape is convex and represents avariance of about 1 to 5 degrees about a longitudinal axis of the capletcore.
 4. The capsule-like medicament of claim 2 wherein the subcoatingon the solid core comprises a mixture of hydroxypropylmethyl celluloseand castor oil.
 5. The capsule-like medicament of claim 2 wherein thesubcoating composition comprises from about 2 to about 8% by weight ofthe total weight of the subcoated caplet core.
 6. The capsule-likemedicament of claim 2 wherein the subcoating composition comprises fromabout 4 to about 6% by weight of the total weight of the subcoatedcaplet core.
 7. The capsule-like medicament according to claim 5 whereinthe castor oil comprises from about 0.1 to about 1.0% by weight of thetotal weight of the subcoated caplet core.
 8. The capsule-likemedicament according to claim 4 wherein the medicament is acetaminophen.9. The capsule-like medicament according to claim 4 wherein themedicament is ibuprofen.
 10. The capsule-like medicament according toclaim 4 wherein the medicament is naproxen.
 11. The capsule-likemedicament according to claim 4 wherein the medicament is loperamide.12. The capsule-like medicament according to claim 4 wherein themedicament comprises a combination of acetaminophen, pseudoephedrine,dextromethorphan and chlorphenarimine.
 13. The capsule-like medicamentaccording to claim 4 wherein the medicament comprises a combination ofacetaminophen and pseudoephedrine.
 14. The capsule-like medicamentaccording to claim 4 wherein the medicament comprises a combination ofibuprofen and pseudoephedrine.
 15. An oral medicament having a smooth,uniform and substantially bubble-free gelatinous outer coatingcomprising a capsule shaped solid core containing a pharmaceuticalactive which has an exterior surface that is coated with in the range offrom about 2 weight percent to about 8 weight percent by weight of thetotal weight of a subcoating composed of a mixture ofhydroxypropylmethyl cellulose and castor oil, wherein the subcoatingprovide an outer subsurface which is coated with a gelatinous coatingthereby providing a capsule-like medicament.
 16. The capsule-likemedicament according to claim 15 wherein the medicament is selected fromthe group consisting of acetaminophen, ibuprofen, loperamide, naproxen,pseudoephedrine, dextromethorphan, chlorphenarimine, and mixturesthereof.
 17. The capsule-like medicament according to claim 15 whereinthe medicament is acetaminophen.
 18. A process for preparing an oralgelatin coated medicament comprising the steps of: compressing a mixtureof a pharmaceutical active and excipients to form a solid core; applyinga subcoating composition comprising a mixture of a water-solublefilm-forming polymer selected from the group consisting of hydroxypropylcellulose, hydroxypropylmethyl cellulose, mixtures of hydroxypropylcellulose and hydroxypropylmethyl cellulose, mixtures of hydroxypropylcellulose and methyl cellulose wherein the hydroxypropyl celluloseconstitutes greater than 50 weight percent but less than 100 weightpercent of the mixture of hydroxypropyl cellulose and methyl cellulose,mixtures of hydroxypropyl cellulose and hydroxyethyl cellulose whereinthe hydroxypropyl cellulose constitutes greater than 80 weight percentbut less than 100 weight percent of the mixture of hydroxypropylcellulose and hydroxyethyl cellulose, mixtures of hydroxypropylmethylcellulose and methyl cellulose wherein the hydroxypropylmethyl celluloseconstitutes greater than 50 weight percent but less than 100 weightpercent of the mixture of hydroxypropylmethyl cellulose and methylcellulose, mixtures of hydroxypropylmethyl cellulose and hydroxyethylcellulose wherein the hydroxypropylmethyl cellulose constitutes morethan 80 weight percent but less than 100 weight percent of the mixtureof hydroxypropylmethyl cellulose and hydroxyethyl cellulose andcombinations of two or more thereof; and castor oil, and applying asmooth outer gelatinous coating to the subcoated solid core to provide asmooth, uniform and substantially bubble free outer coating appearanceto the oral medicament.
 19. The process of claim 18 wherein the filmforming polymer is hydroxypropylmethyl cellulose.
 20. The process ofclaim 18 wherein the medicament is selected from the group consisting ofacetaminophen, ibuprofen, loperamide, naproxen, pseudoephedrine,dextromethorphan, chlorphenarimine and mixtures thereof.
 21. The processof claim 18 wherein the smooth outer coating comprises a gelatin whichis a mixture of bone gelatin and pork gelatin.
 22. The process of claim20 wherein the gelatin outer coating is applied at temperatures in therange of about 35 to 55° C.
 23. The process of claim 22 wherein themedicament is acetaminophen and the gelatin outer coating is applied ata temperature of about 40° C.
 24. The process of claim 20 wherein thegelatin outer coating is applied at temperatures in the range of about40 to 50° C.
 25. The process of claim 18 wherein the subcoatingcomprises in the range of from about 2 weight percent to about 8 weightpercent of the total weight of the oral gelatin coated medicament. 26.The process of claim 20 wherein the subcoating comprises in the range offrom about 6 weight percent to about 8 weight percent of the totalweight of the oral gelatin coated medicament.
 27. The process of claim20 wherein the solid caplet core is compressed and formed into a slightconvex bowed shape.
 28. The process of claim 20 wherein the gelatinouter-coating is applied by dipping the subcoated capsule-likemedicament into one or more gelatin solutions.
 29. A capsule-likemedicament comprising a solid caplet core which has a slight bowedshape.
 30. The capsule-like medicament of claim 29 wherein the bowedshape is convex and represents a variance of about 1 to 5 degrees abouta longitudinal axis of the caplet core.